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New treatment option for Transtibial Amputation
Official title Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
ClinicalTrials.gov ID: NCT07216183
What this study is testing
- What it's testing
- The goal of this clinical trial is to 1) demonstrate the feasibility of monitoring pressure, temperature, and lactic acid density of sweat inside the prosthetic socket, and 2) verify the relationship between mechanical pressure and Lactic acid density of sweat for lower limb amputees among transtibial amputees. The main questions it aims to answer are: Is it feasible to reliably monitor pressure, temperature, and lactic acid density inside the prosthetic sockets simultaneously?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Be 18 years or older
- Have a unilateral lower limb amputee (below the knee). The tibial length on the residual limb must be greater than half of the length of the tibial...
- Have an amputation that occurred over 2 years ago
- Have at least 1 year of experience using your prosthetic leg
- Have used the current socket for at least 6 months without a significant skin issue or major modification
You likely can't join if
- Have a cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the...
- Have any neuropathy observed on the residual limb
- Experience numbness, tingling, muscle weakness, and/or pain in your residual limb
- Weigh more than 300lbs
- Do not want to take photos
- Are pregnant or plan to get pregnant
See the full eligibility criteria
- Be 18 years or older
- Have a unilateral lower limb amputee (below the knee). The tibial length on the residual limb must be greater than half of the length of the tibial on the unaffected side
- Have an amputation that occurred over 2 years ago
- Have at least 1 year of experience using your prosthetic leg
- Have used the current socket for at least 6 months without a significant skin issue or major modification
- Be able to comfortably walk 6 mins (with prosthetic legs) without pausing to rest
- Be willing to come to North Carolina State University's Centennial Campus to participate in research and be photographed while doing research activities
- Have a cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
- Have any neuropathy observed on the residual limb
- Experience numbness, tingling, muscle weakness, and/or pain in your residual limb
- Weigh more than 300lbs
- Do not want to take photos
- Are pregnant or plan to get pregnant
- Are allergic to latex, which is often contained in medical tapes.
- If you are using medication to control sweat on your residual limb, and your medical provider does not think that it is OK to avoid these medications for 48 hours.
The study team makes the final eligibility decision.
Where it's taking place
- Raleigh, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Raleigh, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.